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Heart transplant protocol and for cause biopsies for Heart Transplant Rejection

N/A
Recruiting
Led By Philip F Halloran, MD PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 month
Awards & highlights

Summary

Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Calibration of Prospera test for T cell-mediated rejection
Calibration of Prospera test for antibody-mediated rejection
Calibration of Prospera test for heart injury
+2 more
Secondary study objectives
Assessment of donor-specific antibody status
Determine if Prospera blood test can replace follow up heart biopsy
Determine if Prospera blood test can replace heart biopsy test

Trial Design

1Treatment groups
Experimental Treatment
Group I: Heart transplant protocol and for cause biopsiesExperimental Treatment3 Interventions
The study population includes patients with a functioning heart transplant undergoing a biopsy for clinical indications as standard of care, or protocol biopsies of heart in high-risk patients, or follow-up after treatment.

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
913 Previous Clinical Trials
390,133 Total Patients Enrolled
Natera, Inc.Industry Sponsor
51 Previous Clinical Trials
41,397 Total Patients Enrolled
One LambdaUNKNOWN
2 Previous Clinical Trials
900 Total Patients Enrolled
~118 spots leftby Dec 2026
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